Pennsylvania Requirement For Medical Device Safety

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Pennsylvania Code

https://www.health.pa.gov/topics/Documents/Laws%20and%20Regulations/Code_28.pdf

Drugs, Devices and Cosmetics Program - Department of …

https://www.health.pa.gov/topics/programs/Pages/Drugs-Devices-and-Cosmetics.aspx

Any business in the Commonwealth of Pennsylvania who is manufacturing, distributing or retailing drugs, medical devices, and/or medicated cosmetics must register with the …

28 Pa. Code Chapter 25. Controlled Substances, Drugs, …

https://www.pacodeandbulletin.gov/Display/pacode?file=/secure/pacode/data/028/chapter25/chap25toc.html

Product containers and their components shall not be reactive, additive or absorptive so as to alter the safety, identity, strength, quality or purity of the drug or its components …

General Safety - Department of Labor & Industry

https://www.dli.pa.gov/Individuals/Labor-Management-Relations/bois/Pages/General-Safety.aspx

The General Safety Law, No.174, P.L.654, provides for the safety and protects the health and morals of persons while employed by prescribing regulations and restrictions …

49 Pa. Code § 18.158. Prescribing and ... - Pennsylvania Bulletin

https://www.pacodeandbulletin.gov/Display/pacode?file=/secure/pacode/data/049/chapter18/s18.158.html

Recordkeeping requirements are as follows: (1) When prescribing a drug, the physician assistant shall keep a copy of the prescription, including the number of refills, in a …

Medical Device Safety | FDA - U.S. Food and Drug …

https://www.fda.gov/medical-devices/medical-device-safety

Medical Device Safety | FDA Medical Device Safety The FDA monitors reports of adverse events and other problems with medical devices and alerts health professionals …

Legal and Normative Requirements: Ensuring the Functional …

https://www.medtechintelligence.com/feature_article/legal-and-normative-requirements-ensuring-the-functional-safety-of-medical-devices/

These general requirements include the requirement that medical electrical equipment and systems must by design ensure single-fault safety or residual risk must …

Board Laws and Regulations - Pennsylvania Department …

https://www.dos.pa.gov/ProfessionalLicensing/BoardsCommissions/Medicine/Pages/Board-Laws-and-Regulations.aspx

Board Laws & Regulations Please note that neither the Board/Commission, nor its staff or counsel, are permitted to provide legal advice or advisory opinions, including …